system and method for treating erectile dysfunction

ABSTRACT

A treatment for male erectile dysfunction comprising separately storing a lyophilized composition of vasoactive agents and a carrier gel, mixing said lyophilized composition of vasoactive agents and said carrier gel creating a homogeneous mixture and applying said homogeneous mixture to the meatus of the glans penis. A system for the treatment of male erectile dysfunction comprising a syringe coupling system for the storage, mixing and application of therapeutic compounds for the treatment of erectile dysfunction, said system further comprising a first syringe and a second syringe. The first and second syringes are filled with a lyophilized composition of vasoactive agents or a carrier gel. The system includes a locking device coupling said syringes to facilitate the transfer of said lyophilized composition of vasoactive agents and carrier gel between the syringes and a penile adapter for applying the therapeutic compounds for the treatment of erectile dysfunction to the meatus of the glans penis.

FIELD OF THE INVENTION

The present invention generally relates to the storage, mixing andapplication of therapeutic compounds and specifically to a system andmethod for treating erectile dysfunction. This invention claims priorityto provisional application 60/930,447, filed May 16, 2007.

BACKGROUND OF THE INVENTION

As used herein, the term “erectile dysfunction” (ED) refers to certaindisorders of the cavernous tissue of the penis and the associated faciawhich produce the inability to attain a sexually functional erection,priapism, the persistent and often painful erection of the penis, andPeyronie's syndrome, a condition characterized by fibrosis of thecavernous tissue and associated painful and distorted erection of thepenis. Erectile dysfunction affects a substantial number of patients. EDcan result from any of numerous physiological or psychological factorswhich cause the blood flow to and from the penis to remain in balancethereby preventing retention of sufficient blood to cause an erection.As used herein, the term “erectile dysfunction” is used in its broadestsense as the inability to attain a sexually functional erection whendesired.

Millions of men suffer from ED and have sought an effective and painfree cure that can be sustained and presents no dangerous side effects.To that end, several therapies have become available, including penileimplants, penile injection of vasoactive compounds, vacuum-constrictiondevices, PDE5 inhibiting pills and topical and intra-urethral vasoactivecompounds. The penile implant was the first effective therapeutic methodused for the treatment of ED (see Wilson S K and Delk J R II. Int J ImpRes. 4:S101-07, 2000). Over the years, implant designs have generallyremained as either semi-rigid or inflatable. Additionally, due to thefact that they require surgery and have led to complications such asinfection, rejection and mechanical failure, implants have usuallyremained as the method of last resort for most men. As a result, despitetheir effectiveness, only about 10-12,000 are placed each year in theUnited States. Therefore most men suffering from ED have searched forother alternatives to treat their condition.

The next effective therapy method used for the treatment of ED waspenile injection with vasoactive drugs. Although this approach has beensuccessful for many men, the drop out rate has proven to be high becausemost men are reluctant to self-inject the drugs and many haveexperienced pain and scarring as a result of the injections.Furthermore, the long-term stability of the compounds used for thismethod requires that they be refrigerated or maintained under specialconditions for transport by the patients. Several patents, includingU.S. Pat. Nos. 3,927,197 and 5,741,523, have been issued for thedevelopment of chemical formulations utilizing vasoactive compounds toreduce pain and improve stability.

Another method for treating ED, which has proven effective for manyusers, is vacuum erection devices with constriction rings. Some currentsystems, including U.S. Pat. No. 4,995,381, have achieved FDA approvalbecause they have been engineered with safety features such as pressuregovernors, quick release valves and safe constriction rings. Like theuse of vasoactive gels, these systems can also be used in combinationwith other therapies. However, the use of vacuum devices withconstriction rings is unattractive to many prospective users because themechanical apparatus can be intimidating and the method is not conduciveto spontaneous use.

The availability of phosphodiesterase type 5 (PDE5) inhibitors has madea great impact on the treatment of ED. These drugs, available in tabletform, have been taken by millions of men and they have also been usedfor men with comorbidities. However, these tablets present some majornegative drawbacks. For instance, PDE5 inhibitors cannot be used for menusing nitroglycerine products or that have a history of retinalproblems. In addition, PDE5 inhibitors have also been shown to causeheadaches and nasal congestion. For these reasons, there are manydropouts associated with these medications; leading to a search foralternative treatments for ED (see Rupesh R et al. J Androl. 26:757-60,2005).

Recently, the use of topical and intra-urethral products has receivedattention because they are readily transportable, minimally invasive andhave the potential for use with combination therapy. Several patentshave been granted to inventors who described topical products anddelivery systems related to the treatment of ED. For example, U.S. Pat.No. 4,801,587 describes a gel containing a combination of vasodilators.The product is placed topically on the penis, and then into the urethrausing a catheter. The urethra was chosen for application because, unlikethe penile skin, the urethral mucosa is not keratinized and containsspecific receptor sites and many other drug products have been placedthere for absorption (see Holstein A F et al. Cell Tiss. Res. 264:23-32,1991, Pudney J and Anderson D J. Amer. J. Path. 147:155-165, 1995 andDeBenedictis T J et al. J Urol. 118:767-769, 1977). U.S. Pat. No.5,242,391 discloses an invention of a coated pellet containingProstaglandin Subgroup 1 (PGE1) and a dispenser for insertion into theurethra. This product has been sold and used in clinical practice underthe trade name MUSE. Although this product has had positive responsesamong a variety of ED patients, many reports also suggest that usershave experienced pain from insertion of the dispenser and a throbbingpain as a direct result of the PGE1 product in 35-60% of the cases (seeLinet et al. NEJM 334:873, 1996).

For this reason, alternative solutions of ED treatment using pre-mixedPGE1 based compositions have been sought. For example, U.S. Pat. No.6,323,241 discloses an invention of a PGE1 gel with several chemicalingredients including penetration enhancers and a buffer system tomaintain a final pH in the range of 3-7.4. While this product wasreported to have a 73.1% satisfaction rate, 14.6% of the patientscomplained of pain (see Zhao D et al. Zhonghua Nan Ke Xue 9:48-50,2003).

It has been suggested that there is a relation to the pain caused bytopical methods and the PH level of the pre-mixed product. Some studieshave shown that higher pH levels have reduced the amount of painassociated with the use of PGE1 (see Moriel E Z and Rajfer J. J Urol.149 1299-300, 1993). However, it is difficult to maintain the pH levelof pre-mixed PGE1 based products because the ingredients may precipitateupon standing at a higher pH. Further disadvantages of pre-mixed PGE1compositions include a short shelf life that requires products to beused immediately to achieve the desired results and the requirement forspecial additives that adds to the cost and complexity of the system.

All of the therapies mentioned above have been used for the definitivetreatment of ED, but each has been shown to have limitations. As aresult, many men are reluctant to try some of these methods and thosewho have used one or more of these methods have discontinued use becauseof side effects or a failure to consistently achieve desired results.Therefore, there is an on-going need for improved methods of treatmentfor men with ED. In accordance, the present system represents asimplified approach to the storage, mixing and intra meatal delivery ofa vasoactive gel.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide asystem and method for the treatment of erectile dysfunction (ED). Themethod of treating erectile dysfunction comprises the steps ofseparately storing a lyophilized composition of vasoactive agents and acarrier gel, mixing the lyophilized composition and the carrier gel tocreate a homogeneous mixture and applying the homogeneous mixture to theglans penis.

Another object of the present invention is that the resultanthomogeneous mixture of vasoactive agents and a carrier gel has a PHlevel above 9 to reduce the pain associated with the application ofvasoactive agents.

Another object of the present invention is to lyophilize the vasoactiveagents. This allows the vasoactive agents to be stored for a longerperiod of time and then to be mixed with the carrier gel immediatelybefore application to maximize results.

Another object of the present invention is to allow the lyophilizedcomposition of vasoactive agents and a carrier gel to be storedseparately from each other. This allows the compositions to have alonger shelf life so the treatment will be available to patients whenneeded and the resulting mixture can be maintained at the desired pHlevel.

It is yet another object of the current invention to provide a system tostore and mix a lyophilized composition of vasoactive agents and acarrier gel.

Another object of the present invention is that the mixing systemcomprises a first and second syringe, each syringe storing either thelyophilized composition of vasoactive agents or the carrier gel. Thesystem also includes a locking device which allows the syringes to becoupled together. The coupled syringes allow for the transfer oflyophilized composition of vasoactive agents and the carrier gel betweenthe two syringes to create a homogeneous mixture. The system alsodiscloses a penile adapter capable of applying the homogeneous mixtureto the glans penis.

Another object of the present invention is to provide a penile adaptercapable of creating a seal with the meatus of the glans penis sotherapeutic compounds can be applied to the meatus of the glans peniswithout any leakage.

Another object of the present invention is that the penile adapter isconfigured to fit over a device which stores and discharges medicinalcompounds, such as a syringe, and allows users to easily and safelyapply the therapeutic agents themselves.

Another object of the present invention is to provide a method ofstoring, mixing and applying a therapeutic compound for the treatment oferectile dysfunction comprising the steps of storing a lyophilizedcomposition of vasoactive agents in a first syringe, storing a carriergel in a second syringe and mixing said lyophilized composition ofvasoactive agents and said carrier gel using a device adapted forcoupling said syringes together, said device allowing the transfer ofsaid lyophilized composition of vasoactive agents and said carrier gelbetween said syringes, the repeated transfer creating a homogeneousmixture for erectile dysfunction treatment. The method also comprisesthe steps of transferring said homogeneous mixture for erectiledysfunction treatment into said first syringe, fitting a penile adapterto said first syringe and discharging said homogeneous mixture forerectile dysfunction treatment into the glans penis.

BRIEF DESCRIPTION OF THE FIGURES

The object and the advantages of various embodiments of the inventionwill become apparent from the following description when read inconjunction with the accompanying drawings wherein,

FIG. 1 is a perspective view of a syringe coupling system, according toan embodiment of the present invention.

FIG. 2 is an enlarged side view of the second syringe shown in FIG. 1.

FIG. 3 is an enlarged side view of the first syringe shown in FIG. 1.

FIG. 4 is an exploded view showing the syringe coupling system shown inFIG. 1.

FIG. 5 a is a perspective view of a penile adapter, according to anembodiment of the present invention.

FIG. 5 b is a cross-sectional view of the penile adapter shown in FIG. 5a.

FIG. 6 is a perspective view of the penile adapter of FIG. 5 a fitted toa syringe.

FIG. 7 is a flow diagram showing the steps of storing, mixing andapplying therapeutic compounds for erectile dysfunction treatment.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The present invention teaches a system and method to treat erectiledysfunction (ED). In its broadest aspect, the invention contemplates amethod of intra meatal delivery of therapeutic agents to the mucosa ofnavicular fossa. The erectile dysfunctions may be so treated withtherapeutic agents comprising one or more drugs capable of producing avasodilatory or other erection inducing effect.

The term “meatus” refers to a natural body opening or canal.

The term “glans penis” refers to the sensitive tip or head of the penis.

The term “mucosa” refers to linings of body cavities which are involvedin absorption and secretion.

The term “navicular fossa” refers to the cavernous portion of theurethra.

The term “lyophilize” refers to a dehydration process typically used topreserve a perishable material or make the material more convenient fortransport.

The term “vasodilator” refers to a drug or chemical that relaxes thesmooth muscle in blood vessels, which causes them to dilate.

The term “vasoactive” refers to a drug or chemical with vasodilatoryproperties.

The therapeutic agents used in the present invention comprise one ormore vasodilators and a vasoactive prostaglandin. Suitable vasodilatorsinclude alpha-adrenergic blockers (e.g., phentolamine or anypharmaceutically acceptable salt of phentolamine) and papaverine or anypharmaceutically acceptable salt of papaverine. Suitable vasodilatorsinclude atropine, niacin, prazosin, doxazosin, terazosin and minoxidiland mixtures thereof. Accordingly, it is appreciated that those skilledin the art may utilize any suitable vasodilatory agent or anypharmaceutically acceptable salts of these vasodilators. Suitablevasoactive prostaglandins include prostaglandin E1, alprostadil,prostaglandin E2, synthetic prostaglandins, misoprostol, enprostil, andanalogs thereof. Accordingly, it is appreciated that those skilled inthe art may utilize any suitable vasoactive prostaglandin.

The present invention discloses the novel approach of using alyophilized composition of one or more vasodilators and a vasoactiveprostaglandin for the treatment of ED. Utilizing a lyophilizedcomposition presents the advantage of an increased shelf life so thatthe therapeutic agents can be stored for a longer period until the useris ready to administer a dosage. In a preferred embodiment, thelyophilized composition of vasoactive agents comprises papaverine,phentolamine and alprostadil. In one embodiment, the lyophilizedcomposition of vasoactive agents comprises 1000 mcg alprostadil, 300 mcgpapaverine and 100 mcg phentolamine. In another embodiment, thelyophilized composition of vasoactive agents comprises 500 mcgalprostadil, 300 mcg papaverine and 100 mcg phentolamine. In yet anotherembodiment, the lyophilized composition of vasoactive agents comprises250 mcg alprostadil, 300 mcg papaverine and 100 mcg phentolamine.Accordingly, it is appreciated that those skilled in the art may use alyophilized composition containing any pharmaceutically effective amountof alprostadil, papaverine and phentolamine.

The use of a lyophilized composition also allows the vasoactive agentsto be stored until the time of application. At the time of application,the lyophilized composition of vasoactive agents is combined with apharmaceutically suitable amount of a carrier gel to create a homogenousmixture to be applied to the glans penis. Suitable carrier gels includehigh weight cellulose gels such as methylcellulose, polyethylene glycol,propylene glycol, glycerin and hydroxyethyl cellulose. Accordingly, itis appreciated that those skilled in the art may utilize apharmaceutically effective amount of any suitable high weight polymergel.

A common problem experienced with pre-mixed gels of the prior art thathigh pH levels could not be maintained. By avoiding the use of pre-mixedgels, the present invention allows the pH level of the final mixture ofvasoactive agents and carrier gel to be maintained. As vasoactive agentshave been shown to cause less pain and discomfort at higher pH levels,in a preferred embodiment, the pH level for the homogenous mixture ofvasoactive agents and carrier gel is greater than 9.

In a preferred embodiment, pain-relieving additives are also added tothe carrier gel to reduce the pain associated with the application ofvasoactive agents to the urethra of the penis. Suitable additivesinclude lactose, molar potassium phosphate, sodium bicarbonate andmixtures thereof. Accordingly, it is appreciated that those skilled inthe art may also utilize any suitable pain relieving additives to becombined with the carrier gel.

FIG. 1 discloses a system for coupling two syringes that can be used tomix a lyophilized composition of vasoactive agents and carrier gel,according to an embodiment of the present invention. The syringecoupling system 10 includes a first syringe 11 and a second syringe 12,which are designed to be coupled together so as to pass the lyophilizedvasoactive agents and carrier gel therebetween. Further disclosure withregard to the configuration and coupling of the syringes and mixing ofcomponents between the two syringes is disclosed in U.S. Pat. No.6,234,196 issued on May 22, 2001 and U.S. Pat. No. 6,610,034 issued onAug. 26, 2003, which are incorporated herein by specific reference.

As shown in FIGS. 1 and 2, second syringe 12 includes a barrel 14 havinga first end 18 and an opposing second end 19. Projecting from the firstend 18 is a tubular tip 21. Slideably disposed within the second end 19of barrel 14 is a plunger 16. Barrel 14 also bounds cavity 24. Cavity 24is configured to slidably receive plunger 16 and to hold either thelyophilized vasoactive agents or carrier gel for mixing and/ordispensing.

Tubular tip 21 of second syringe 14 is shown having an exterior surface28 and an opposing interior surface 29. Interior surface 29 bounds achannel 26 in fluid communication with cavity 24. A central longitudinalaxis 34 extends through cavity 24 and chamber 26. In the embodimentdepicted, the tubular tip 21 has a smaller outer diameter than thebarrel 14. In alternative embodiments, however, the tubular tip 21 mayhave the same or other varied diameter relative to barrel 14. In suchembodiments, the tubular tip 21 merely defines one end of barrel 14.

Still referring to FIGS. 1 and 2, outwardly projecting from the exteriorof the tubular tip 21 is a pair of spaced apart first threads 22 and 23.In one embodiment, first threads 22 and 23 comprise a pair of right handthreads. In the embodiment depicted, each of first threads 22 and 23only partially encircle tip 21. In alternative embodiments, one or bothof first threads 22 and 23 may completely encircle tip 21 one or moretimes.

Referring now to FIGS. 1 and 3, the first syringe 11 includes a barrel13 having a first end 20 and an opposing second end 27. Slidablydisposed within the second end 27 of barrel 13 is a plunger 15. Barrel13 bounds a cavity 25 that is configured to slidably receive plunger 15and to hold either the lyophilized vasoactive agents or carrier gel formixing and/or dispensing. A tubular collar 30 having an exterior surface35 and an opposing interior surface 36 projects from the first end 20 ofbarrel 13. Inwardly projecting from interior surface 36 of collar 30 isa pair of engagement threads 31 and 32. Interior surface 36 bounds achannel 38 that is in fluid communication with cavity 25. A centrallongitudinal axis 37 extends through cavity 25 and chamber 38.

As depicted in FIG. 4, the first syringe 11 and second syringe 12 arelocked together such that tubular tip 21 can be selectively receivedwithin channel 25 and secured therein by threaded engagement betweenfirst threads 22, 23 and engagement threads 31 and 32. In this coupledengagement, cavities 24 and 25 are in fluid communication. Byselectively advancing one of plungers 15 or 16, the component within thesyringe of the advancing plunger is passed into the cavity of theopposing syringe. Furthermore, by selectively advancing and retractingeach of plungers 15 and 16, the lyophilized vasoactive agents andcarrier gel within each of syringes 11 and 12 can be passed back andforth between the two syringes, thereby mixing the two components andcreating a homogeneous mixture for erectile dysfunction treatment.

Referring now to FIGS. 5 a, 5 b and 6, a penile adapter, according to apreferred embodiment of the present invention, will be described. Asbest seen in FIG. 5 a, the penile adapter is formed from a top portion51 and bottom portion 52. The top portion 51 has a substantiallyspheroidal dome shape and is designed to create a seal with the meatusof the glans penis. The slope of the top portion 51 allows it to createa substantially liquid tight seal with any size meatus. When the penileadapter 50 is placed on the glans penis, the top portion 51 fits withinthe meatus to prevent the therapeutic compounds being applied to themucosa of the urethra from being lost or leaking onto the penis. Inaddition, the top portion 51 is designed such that no portion of adevice being used to discharge therapeutic compounds penetrates past themeatal opening of the glans penis. This prevents any unnecessarydiscomfort or pain during the application of therapeutic compounds. Theplacement of the top portion 51 of the penile adapter also acts tomassage the meatus of the glans penis, which has shown to improveabsorption and the effectiveness of the therapeutic agents. The bottomportion 52 of the penile adapter 50 has a substantially cylindricalshape and extends perpendicularly from the top portion 51 of the penileadapter 50. As shown in FIG. 5 b, the penile adapter 50 has a rearwardopen channel 53 in the bottom portion 52 and a forward open channel 54in the top portion 51. The rearward open channel and the forward openchannel are in fluid communication to facilitate the flow of therapeuticcompounds. The bottom portion 52 of the penile adapter 50 can beremoveably attached to a device, such as a syringe, that dischargesmedicinal compounds. The penile adapter can be made from apolyethylene-based material in order to not cause irritation to humantissue. FIG. 6 depicts a preferred embodiment wherein the penile adapter50 is fit to a syringe.

Referring now to FIG.7, the method of storing, mixing and applyingtherapeutic agents for the treatment of erectile dysfunction will bedescribed. In step 1, a pharmaceutically suitable amount of alyophilized composition of vasoactive agents and carrier gel are storedseparately in two syringes. By separately storing the ingredients, theshelf life of the vasoactive agents is lengthened. There is also no needfor additives to maintain the homogeneous mixture or desired pH level.

In step 2, the lyophilized composition of vasoactive agents and carriergel are vigorously mixed using a syringe coupling system. Using asyringe coupling system, the two syringes are linked to allow transferof the vasoactive agents and carrier gel therebetween. After thesyringes are securely locked to each other, the plungers of each syringeare alternately depressed and retracted so that the product within onesyringe will be transferred to the other syringe. This process isrepeated rapidly about 20 to 30 times to insure that the vasoactiveagents and gel become a homogeneous mixture. The locking system willpermit a series of vigorous and repeated transfers leading to completecombination of the products without any internal precipitate formation.The final homogeneous mixture creates a gel in which the products aredissolved completely and are available at full strength for absorptionthrough the mucosa of the urethra. The final mixture will have a pHabove 9 for maximum effectives and to reduce the pain duringapplication. Although the higher pH has produced precipitation in othersituations, the vigorous mixing achieved with the present inventionproduces a homogeneous gel that is able to maintain at the desired pHlevel. At step 3, the homogeneous mixture is transferred into thesyringe which is configured to accept the bottom portion of the penileadapter. The other syringe can then be disconnected and discarded.

At step 4, the penile adapter is securely fit to the syringe containingthe homogenous mixture. Finally, at step 5, the penile adapter is placedover the meatus of the glans penis. The shape of the penile adaptercreates a seal with the meatus so that the homogeneous mixture can beapplied to the urethra without any leakage. The shape of the penileadapter also prevents any penetration beyond the meatal opening toprevent pain and discomfort during application. The homogenous mixturecan then be discharged from the syringe, through the penile adapter anddirectly into the navicular fossa. The homogeneous mixture is thenrapidly absorbed through the mucosa of navicular fossa within minutes.

EXAMPLE 1

The system and method for treating erectile dysfunction described abovewas evaluated for administration at the urethral meatus. In this test,Erection Hardness Scores (EHS) and penile rigidity studies were recordedafter the mixture of lyophilized vasoactive agents and a carrier gel wasused on forty-two men with mixed morbidities who failed with PDE5 oralagents. Sixteen of the men were on antihypertensive meds, twelve hadtype II diabetes, eight had high cholesterol and six were post radicalprostatectomy. Ten of the men tested also had comorbidies. Prior toadministration of the mixture of lyophilized vasoactive agents and acarrier gel, an EHS for each man was recorded after the use of an oralagent. The lyophilized vasoactive agents and 0.3 ml of carrier gel weremaintained in separate interlocking syringes at room temperature untilthe time of use. The final preparation was completed by vigorous mixingbetween the interlocking syringes as described in the specificationabove. The mixture was inserted painlessly into the urethral meatus andthe patient massaged the outer glans for two minutes to promoteabsorption. There was no other form of stimulation. After application,an EHS was recorded for each patient. In addition, nine had measurementof buckling pressures and seven had rigiscans. For all forty-twopatients (mean age 55.2 yrs), the EHS was recorded as 1 after use of theoral agents (penis was larger but not hard), but twenty-two of thesepatients actually had no increase in size. After the application of themixture of vasoactive agents and gel, the mean EHS was 2.2; with elevenpatients having an EHS of 3 (26.1%) and 6 with an EHS of 4 (16.6%).Thus, 40.4% of the study group had erections that were sufficient forpenetration. In those with an ESH of 4, the buckling pressure was >90 mmHg. The rigiscans provided real time information about the gel responseand documented some tumescence in all cases. The result of the testsshowed that the application of a lyophilized composition of vasoactiveagents and a carrier gel mixed immediately before applicationeffectively treated erectile dysfunction and may have several advantagesover oral agents and intracavernous injections.

Finally, the present invention may be embodied in other specific formswithout departing from its spirit or essential characteristics. Thedescribed embodiments are to be considered in all respects only asillustrative and not restrictive. The scope of the invention is,therefore, indicated by the appended claims rather than by the foregoingdescription. All changes which come within the meaning and range ofequivalency of the claims are to be embraced within their scope.

1. A method for the treatment of male erectile dysfunction comprisingthe steps of: storing a lyophilized composition of vasoactive agentsseparately from a carrier gel; mixing said lyophilized composition ofvasoactive agents and said carrier gel to create a homogeneous mixturefor erectile dysfunction treatment; and applying said homogeneousmixture to a meatus of a glans penis.
 2. The method claim 1, whereinsaid lyophilized composition of vasoactive agents comprises one or morevasodilators and a vasoactive prostaglandin.
 3. The method of claim 2,wherein said vasoactive prostaglandin is selected from the groupconsisting of prostaglandin E1, alprostadil, prostaglandin E2, syntheticprostaglandins, misoprostol, enprostil, and analogs thereof.
 4. Themethod of claim 2, wherein said vasodilators comprises analpha-adrenergic blocker and a phosphodiesterase inhibitor.
 5. Themethod of claim 2, wherein said vasodilators are selected from the groupconsisting of papaverine, phentolamine, atropine, niacin, prazosin,doxazosin, terazosin, minoxidil and mixtures thereof.
 6. The method ofclaim 2, wherein said lyophilized composition of vasoactive agentscomprises alprostadil, papaverine and phentolamine.
 7. The method ofclaim 1, wherein said carrier gel is a high-weight cellulose based gel.8. The method of claim 1, wherein said carrier gel further comprises atleast one pain-reducing additive.
 9. The method of claim 1, wherein saidhomogeneous mixture for erectile dysfunction treatment has a pH level ofat least
 9. 10. A syringe coupling system for the storage, mixing andapplication of therapeutic compounds for the treatment of erectiledysfunction, said system further comprising: a first syringe having afirst cavity wherein a lyophilized composition of vasoactive agents isstored within said first cavity; a second syringe having a second cavitywherein a carrier gel is stored within said second cavity; a lockingdevice adapted for coupling said first and said second syringes togetherto transfer said lyophilized composition of vasoactive agents and saidcarrier gel between said first and second syringes, wherein said firstand second cavities are in fluid communication; and a penile adapterhaving a bottom portion for attachment to one of said first or saidsecond syringes and having a hole therethrough for transferring saidtherapeutic compounds from one of said first or said second syringe to ameatus of a glans penis.
 11. The syringe coupling system of claim 10,wherein said locking device further comprises: a tubular member havingan interior surface and an exterior surface, said tubular member havinga longitudinal axis extending therethrough, wherein said tubular memberis a tip of said first syringe; a pair of threads outwardly projectingfrom the exterior surface of said tubular member at least partiallyencircling said tubular member, at least a portion of each of the pairof threads disposed in a plane perpendicular to said longitudinal axisof said tubular member, said threads bounding a thread groove; a collarmember having an interior surface and an exterior surface, said collarmember having a longitudinal axis extending therethrough, wherein saidcollar member is a tip outlet tip of said second syringe; and a pair ofengagement threads outwardly projecting from the interior surface ofsaid collar member, at least a portion of each of the engagement threadsbeing disposed in a plane perpendicular to said longitudinal axis ofsaid collar member; wherein said collar member of said second syringe isconfigured to accept said tubular member of said first syringe such thatsaid threads couple with said engagement threads.
 12. A penile adapterfor use in the application of therapeutic compounds for the treatment oferectile dysfunction, said penile adapter comprising: a top portionhaving a substantially spheroidal dome shape having an open channeltherethrough, said top portion shaped to substantially seal a meatus ofa glans penis; and a bottom portion having a substantially cylindricalshape having an open channel therethrough, said bottom portion beingremovably attached to a device which stores and discharges medicalcompounds; wherein said open channel of the top portion is in fluidcommunication with said open channel of the bottom portion to facilitatethe flow of said therapeutic compounds from said device to the meatus ofthe glans penis.
 13. The penile adapter of claim 12, wherein said devicewhich stores and discharges medical compounds is a syringe.
 14. Thepenile adapter of claim 12, wherein said top portion of the penileadapter is further shaped to prevent penetration of the adapter past ameatal opening of the penis.
 15. The penile adapter of claim 12, whereinsaid penile adapter is made from a polyethylene based material.
 16. Amethod of applying therapeutic compounds for the treatment of erectiledysfunction comprising the steps of: storing a lyophilized compositionof vasoactive agents in a first syringe; storing a carrier gel in asecond syringe; mixing said lyophilized composition of vasoactive agentsand said carrier gel to create a homogeneous therapeutic compound usinga locking device, said device allowing the transfer of said lyophilizedcomposition of vasoactive agents and said carrier gel between saidsyringes, the repeated transfer creating a homogeneous mixture forerectile dysfunction treatment; transferring said homogeneous mixturefor erectile dysfunction treatment into said first syringe; fitting apenile adapter to said first syringe; and discharging said homogeneousmixture for erectile dysfunction treatment onto a meatus of a glanspenis.